CUSTOMIZE Implementation Study
For many offices, prescribing CABENUVA may be a departure from typical HIV practice patterns. The results from CUSTOMIZE may help improve the implementation of CABENUVA from the perspective of people living with HIV, the healthcare providers administering CABENUVA, and the healthcare systems facilitating it.1
CUSTOMIZE results are descriptive in nature and should not be used to infer clinical efficacy or safety.
CUSTOMIZE Study Design
CUSTOMIZE was a longitudinal, observational, implementation-effectiveness study
Primary objective2: To evaluate acceptability, appropriateness, and feasibility of delivering CABENUVA
- Acceptability and appropriateness were assessed by providers (physicians, nurses/injectors, and office staff) and patients
- Feasibility was assessed by providers
Secondary objectives included2: To evaluate facilitators and barriers for providers and patients
Provider and Patient Population Details
- 3 provider types: 9 physicians/principal investigators, 9 nurses/injectors, and 8 office administrators
- 5 clinic types: AHF clinic (Miami, FL), HMO (Sacramento, CA), university (Jackson, MS; Jacksonville, FL), private practice (Atlanta, GA; Detroit, MI), and FQHC (Dallas, TX; Kansas City, MO; Washington, DC*)
*Washington, DC, dropped out after baseline provider surveys and interviews were completed.2
FQHC=Federally Qualified Health Center; HMO=health maintenance organization.
- Age: 61% were 20-39 years of age and 39% were ≥40 years of age
- Gender: 87% were male and 13% were female
- Race: 59% were White, Caucasian, or European Heritage, 35% were Black or African American, 5% were American Indian or Alaska Native, 2% were Black or African American and White, Caucasian, European Heritage
Implementation study timeline
The CUSTOMIZE implementation study was conducted through a combination of surveys and semi-structured interviews across a range of clinic types.2 In semi-structured interviews, facilitators were provided with a list of predefined questions based on the consolidated framework for implementation research. This was a guide for the qualitative assessment rather than a script. The interviewer had the freedom to ask appropriate follow-up questions and expand on topics ad hoc if a participant brought up interesting points.2
At baseline, 109 patient participants were surveyed, and a subset of 34 patients were interviewed. The subset of patients (roughly 6 patients per clinic) was selected to participate in interviews via a randomization scheme intended to provide a nonbiased selection of patients from each site.2 At Month 12, 102 participants completed surveys. Reasons recorded for patients withdrawing from CUSTOMIZE included relocation to different cities where CUSTOMIZE clinic sites were not present, death, and intolerance to injections due to injection site pain, recorded as adverse effects.2
Graphic is meant to show passage of time and is not to scale.
Implementation Study Results
Using a 5-point rating scale, providers and patients responded to 4-item surveys that assessed the acceptability and appropriateness of an implementation process; only providers responded to the third survey that assessed feasibility. The table below presents a description of the various components included in the surveys used throughout CUSTOMIZE.1,2
AIM=Acceptability of Intervention Measure; BI=Barriers to Implementation; FIM=Feasibility of Implementation Measure; IAM=Intervention Appropriateness Measure.
CABENUVA implementation shown to be acceptable by providers and patients
The chart below presents the mean proportion of providers or patients who agreed or completely agreed with each of the 4 AIM statements: CABENUVA meets my needs (patients) or approval (providers); CABENUVA is appealing to me; I like the idea of CABENUVA; and I welcome CABENUVA.
ACCEPTABILITY OF IMPLEMENTATION MEASURE1
CABENUVA implementation shown to be appropriate by providers and patients
The chart below presents the mean proportion of providers or patients who agreed or completely agreed with each of the following 4 IAM statements: CABENUVA is fitting; CABENUVA is suitable; CABENUVA is applicable; and CABENUVA is a good match.
INTERVENTION APPROPRIATENESS MEASURE1
CABENUVA implementation shown to be feasible by providers
The chart below presents the mean proportion of providers who agreed or completely agreed with each of the following 4 Feasibility of Implementation Measure statements: CABENUVA seems implementable; CABENUVA seems possible; CABENUVA seems doable; and CABENUVA seems easy to administer.†
Serious post-injection reactions have occurred with inadvertent (partial) intravenous administration of CABENUVA. CABENUVA is administered monthly by 2 intramuscular injections by a healthcare provider. Please see Instructions for Use for complete preparation and injection instructions.
FEASIBILITY OF IMPLEMENTATION MEASURE1
CABENUVA is administered as 2 intramuscular injections at separate gluteal sites by a healthcare professional. Prior to initiating treatment with CABENUVA, prescribe cabotegravir 30-mg and rilpivirine 25-mg oral tablets, both taken once daily with a meal, for approximately 1 month (at least 28 days) to assess tolerability. Adherence to the monthly injection dosing schedule is strongly recommended.
Most perceived barriers identified by providers at baseline to implementation decreased by Month 12
For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their current experiences with implementing the CABENUVA treatment at the time of the baseline and Month 12 surveys.2 Each bar represents the proportion of clinic staff who agreed or completely agreed, using a 1-5 rating scale where 1=completely disagree and 5=completely agree.2 The top 3 barriers at baseline were focused around patients’ ability to make it to their monthly appointments.1
TOP-RATED PROVIDER-REPORTED BARRIERS TO IMPLEMENTATION (BASELINE VS MONTH 12)
Overall, 83% of patients experienced at least one ISR through Week 48 in ATLAS and FLAIR. The most commonly reported ISR was localized pain/discomfort (79%) regardless of severity or relatedness.
ISR=injection site reaction.
At Month 12, HCPs were asked the following question:
HOW MANY MONTHS DID IT TAKE TO IMPLEMENT CABENUVA OPTIMALLY IN YOUR CLINIC/PRACTICE?1‡
‡Does not add up to 100% because of rounding.
Insights From CUSTOMIZE
Treatment considerations are summarized from data collected through qualitative interviews with staff study participants throughout CUSTOMIZE.2
All sites suggested that patients avoid sitting after an injection to help manage injection pain, and three-quarters of sites suggested light exercise (stretching or walking); patients were also encouraged to use a hot or cold pack.2
Healthcare providers must evaluate individual patients on a case-by-case basis before making any treatment recommendations. Data were anecdotal and not based on clinical results.2
The most common adverse reactions in ATLAS and FLAIR (Grades 1-4) observed in ≥2% of subjects receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.3
11 (n=11/23) providers indicated instances where patients needed to switch to oral therapy due to a positive COVID-19 test or exposure2 during quarantine, but providers reported that, overall, this process was not difficult.2 If oral treatment will continue for more than 2 months, an alternative fully suppressive regimen should be chosen based on treatment history and the availability of resistance testing results.3,4
CUSTOMIZE was conducted prior to FDA approval of CABENUVA; therefore, acquisition process for products may have differed from what is currently available.
At Month 12, 4 providers (n=4/23) noted that it would be helpful to have face-to-face injection education and additional information on CABENUVA treatment post-commercialization.2
At Month 12, 16 providers (n=16/23) observed that monthly visits helped support2:
- Improvement in patient engagement and relationships (n=5/23)
- Discussion of sexually transmitted diseases and screening (n=4/23)
- Patients being more engaged in their health concerns (n=4/23)
- The ability to address patient issues more quickly (n=4/23)
“Well, I’ve had a pretty positive experience with the injection treatments. It’s definitely something that I prefer over oral pills. I like being able to keep it private, like not having to have medications in the medical cabinet, or having to go take medications if, you know, you have guests over or stuff like that.”
— PATIENT, AHF§
§This patient quote was collected at Month 12 interviews. Patients were asked how satisfied they were with CABENUVA.
At Month 4 interviews, when asked to discuss the feasibility of implementing CABENUVA, a provider noted that it was helpful when patients called the clinic 30 minutes prior to their arrival so that their CABENUVA injections could be prepared.5
CABENUVA should be removed from the refrigerator so it can come to room temperature at least 15 minutes prior to administration. The vials may remain in the carton at room temperature for up to 6 hours. If not used within 6 hours, the medication must be discarded.2 Please refer to Instructions for Use for preparation instructions.
At Month 12, most providers made minimal or no changes to implement CABENUVA. However, some providers mentioned making a few logistical changes, such as2:
- Hiring additional staff (n=14/23)
- Acquiring additional refrigerators (n=6/23)
- Finding additional clinic space for exam rooms and storage (n=4/23)
- Expanding clinic hours (n=4/23)
At Month 12, 5 providers (n=5/23) mentioned that teamwork and team communication were key strategies for success.2
- Czarnogorski M, Garris C, D'Amico R, et al. CUSTOMIZE: overall results from a hybrid III implementation-effectiveness study examining implementation of cabotegravir and rilpivirine long-acting injectable for HIV treatment in US healthcare settings; final patient and provider data. Presented at the 11th IAS Conference on HIV Science, July 18-21, 2021, Berlin, Germany. Presentation PED416.
- Data on file, ViiV Healthcare.
- CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services. Accessed April 23, 2021. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adultandadolescentGL.pdf.
- Czarnogorski M, Garris C, Wannamaker P, et al. Qualitative findings from a hybrid III implementation-effectiveness study to explore perspectives of healthcare staff on early implementation of cabotegravir and rilpivirine long-acting injectable in the United States (CUSTOMIZE). Poster presented at: IDWeek 2020; October 21-25, 2020. Poster 1037.